Hip OsteoarthritisNCT02085824
Comparison of Blood Loss Following Total Hip Arthroplasty With the Use of Three Thromboprophylactic Regimes: Dabigatran, Enoxaparin and Rivaroxaban.
A study testing Enoxaparin, rivaroxaban and dabigatran in people with Hip Osteoarthritis and Blood Loss, run by Centre of Postgraduate Medical Education at 1 site in Poland.
Trial summary
The purpose of this study is to determine which of the following drugs: enoxaparin, dabigatran and rivaroxaban causes least blood loss after total hip replacement (THR). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Osteoarthritis, Blood Loss
- What is being tested?
- Enoxaparin, rivaroxaban and dabigatran
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePoland
- Study dates
- Jul 2012to Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primary, end-stage hip osteoarthritis requiring total hip arthroplasty
Who cannot join
- inflammatory arthropathies
- liver disorders
- neoplastic conditions
- clotting disorders
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Prof. A. Gruca Teaching Hospital, The Medical Centre of Postgraduate Education
Otwock, Woj. Mazowieckie, 05-400
Marcin K Wasko, M.D., Ph.D.
About this study
The purpose of this study is to determine which of the following drugs: enoxaparin, dabigatran and rivaroxaban causes least blood loss after total hip replacement (THR).
- Conditions
- Hip Osteoarthritis, Blood Loss
- Being tested
- Enoxaparin, rivaroxaban, dabigatran
- Medical subject headings
- Osteoarthritis, Hip, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnoxaparinDrug
rivaroxabanDrug
dabigatranDrug
| Study group | Role | What they receive |
|---|---|---|
| enoxaparin | Experimental | enoxaparin 40mg 1x1 s.c. daily, once preoperatively and then daily for 28 days Receives: Drug: Enoxaparin |
| rivaroxaban | Experimental | rivaroxaban 10 mg 1x1 p.o. daily for 28 days after the surgery Receives: Drug: rivaroxaban |
| dabigatran | Experimental | dabigatran 110 mg 1x1 p.o. postoperatively and then 1x2 p.o. for 27 days after the surgery Receives: Drug: dabigatran |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total blood loss by the 3rd postoperative day
Measured for each individual. Measured according to the formula described by Nadler, Hidalgo and Bloch (Prediction of blood volume in normal human adults. Surgery 1962;51:224-32).
Measured: 3rd day postoperatively
Secondary outcomes (2)
Drop in the haemoglobin value between 3rd day postop and preoperative
Difference between haemoglobin on the 3rd postopertive day and day before operation
Measured: 3rd day postopertively
Wound healing disturbances according to the definition of Centers for Disease Control and Prevention
Wound healing disturbances - diagnosis to be made according to the definition of Centers for Disease Control and Prevention (Mangram, Horan, Pearson, Silver and Jarvis. Guideline for prevention of surgical site infection, 1999. Hospital Infection Control Practices Advisory Committee. Infect Control Hosp Epidemiol. 1999 Apr;20(4):250-78)
Measured: 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2014 (estimated)
- Study startJul 2012
- Primary completionApr 2014 (estimated)
- Study completionApr 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre of Postgraduate Medical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcin Wasko MD PhD, Centre of Postgraduate Medical Education
- Investigators
- Marcin K Wasko, M.D., Ph.D., Principal investigator, The Medical Centre of Postgraduate Education, Department of Orthopaedics and Inflammatory Disorders of Locomotor System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02085824
- Sponsor's protocol ID
- CPX-2012
- Status last verified
- Mar 2014
- First submitted
- 7 Mar 2014
- Last updated
- 14 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Blood Loss Following Total Hip Arthroplasty With the Use of Three Thromboprophylactic Regimes: Dabigatran, Enoxaparin and Rivaroxaban.
- ClinicalTrials.gov ID
- NCT02085824
- Acronym / sponsor ID
- CPX-2012
- Conditions
- Hip Osteoarthritis, Blood Loss
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centre of Postgraduate Medical EducationUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Apr 2014 (estimated)
- Study completion
- Apr 2014 (estimated)
- First posted
- 13 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine which of the following drugs: enoxaparin, dabigatran and rivaroxaban causes least blood loss after total hip replacement (THR).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| enoxaparin | Experimental | Drug: Enoxaparinenoxaparin 40mg 1x1 s.c. daily, once preoperatively and then daily for 28 days |
| rivaroxaban | Experimental | Drug: rivaroxabanrivaroxaban 10 mg 1x1 p.o. daily for 28 days after the surgery |
| dabigatran | Experimental | Drug: dabigatrandabigatran 110 mg 1x1 p.o. postoperatively and then 1x2 p.o. for 27 days after the surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- primary, end-stage hip osteoarthritis requiring total hip arthroplasty
Key exclusion criteria (4 listed)
- inflammatory arthropathies
- liver disorders
- neoplastic conditions
- clotting disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enoxaparin | Drug | enoxaparin |
| rivaroxaban | Drug | rivaroxaban |
| dabigatran | Drug | dabigatran |
Primary outcome
Total blood loss by the 3rd postoperative day
Time frame: 3rd day postoperatively
Measured for each individual. Measured according to the formula described by Nadler, Hidalgo and Bloch (Prediction of blood volume in normal human adults. Surgery 1962;51:224-32).
2 secondary outcomes
Drop in the haemoglobin value between 3rd day postop and preoperative
Time frame: 3rd day postopertively
Wound healing disturbances according to the definition of Centers for Disease Control and Prevention
Time frame: 3 months postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcin K Wasko, M.D., Ph.D. principal investigator
The Medical Centre of Postgraduate Education, Department of Orthopaedics and Inflammatory Disorders of Locomotor System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enoxaparin, rivaroxaban and dabigatran in people with Hip Osteoarthritis and Blood Loss, run by Centre of Postgraduate Medical Education at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marcin K Wasko, M.D., Ph.D. (+48227794031 ext. 384, m.wasko@cmkp.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total blood loss by the 3rd postoperative day (time frame: 3rd day postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2014.